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OpenTrials
Completed

NCT Number: NCT01009606

Cardiopulmonary Resuscitation Witnessing by a Relative

The bereavement generated by the loss of a family member can induce pathological situations: depressive state, anxiety, post-traumatic stress disorder and complicated grief. These morbid factors can be influenced by the death circumstances and in particular by the possibility given to the family to attend the medical management of the patient. This clinical trial aims to evaluate the psychological consequences of bereavement on the relatives according to the possibility of witnessing the cardiopulmonary resuscitation of a family member. This possibility lies within the scope of a strategy of global management of the relatives.

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Key information

Conditions

Cardiac Arrest Cardiovascular Diseases Disease Attributes Emergencies Heart Arrest Heart Diseases Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

SAMU 93 - Hôpital Avicenne

Bobigny, Île-de-France Region, 93000, France

About this study

This clinical trial aims to compare the presence of post-traumatic stress disorder on a relative related to the death of a family member:

Test group: the medical team will propose to the relative to witness the cardiopulmonary resuscitation.

Control group: the medical team will not modify its usual management of care.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient victim of a cardiac arrest and resuscitation initiated
  • Occurrence of cardiac arrest at home
  • Presence of a relative :
  • husband or spouse
  • father or mother
  • son or daughter
  • brother or sister
  • Patient's age ≥ 18 years
  • Relative's age ≥ 18 years
  • Consent of the relative to the participation in the study

Exclusion criteria

  • No understanding of the explanations (language problem, important agitation)
  • Non-affiliated to social security

Treatment and study plan

usual strategy

Other

Usual strategy

Modified strategy

Other

Proposition to a relative to witness the cardiopulmonary resuscitation of a family member and debriefing ot the situation

Primary outcomes

  1. Percentage of relatives having a score of the Impact of Events Scale (IES) > 30

    Time frame: 3 months

Secondary outcomes

  1. Psychological questionnaires as the hospital anxiety and depression scale (HAD), the Mini International Neuropsychiatric Interview (MINI), the Inventory of Complicated Grief (ICG)

    Time frame: 3 and 12 months

  2. Psychological follow-up

    Time frame: 3 months

  3. Suicide

    Time frame: 3 and 12 months

  4. Medico-legal recourse

    Time frame: 12 months

  5. Quality of the cardiopulmonary resuscitation

    Time frame: day 0

  6. Questionnaire evaluating the stress of the medical and paramedical team

    Time frame: day 0

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Ministry of Health, France

Registry information

Official study title

Interest for a Relative of Seeing Himself Proposing to Witness Resuscitation of a Family Member Victim of a Cardiac Arrest

Acronym: PRESENCE

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Nov 9, 2009
Registry last updated
Jan 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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